Engineering Specialist

Job Title: Engineering Specialist

Location: Indianapolis IN 46268

Duration: 06 Months

Job Description:

• This is one year contract engineering role support a new greenfield Isotope Manufacturing Facility in Indianapolis.
• It is an onsite role.
• This role will be responsible for supporting the design, installation, and validation for the sterile purification and recycling isolators into commercial production.
• This role will be a project team member in the Indy Site ITOT team and will likely support Automation activities in support of a validation team on a second shift starting initially on day shift moving to a second shift which for an extended period may require 9-10 hours per day 6 days per week during the critical validation period as the equipment completes PQ activities.

Education:

• Bachelor's degree in Engineering, Computer Science, Automation, or related field with 7 years of relevant engineering experience in the Pharmaceutical or Chemical industry; or 10 years of relevant engineering experience in lieu of a degree.

Role and Responsibilities:

• Hands-on experience in configuring and troubleshooting PLC systems (Siemens preferred, Rockwell).
• Solid understanding of Computer System Validation (CSV) for qualifying automation systems.
• In-depth knowledge of FDA regulations, including 21 CFR Part 11 and GMP systems.
• Experience in pharmaceutical GMP manufacturing operations, including aseptic fill/finish and/or radio pharmacy, is preferred.
• Strong knowledge of ISA 95 and S88 standards for industrial automation and batch process control.
• Strong oral and written communication skills with the ability to collaborate effectively across cross-functional teams.
• Proven experience in stakeholder management and building productive relationships at all levels of the organization.
• Solid project management skills, including planning, execution, validation, and delivery of automation projects.
• Demonstrated ability to act with a sense of urgency to complete tasks efficiently.